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YY/T 0884-2013 English PDF

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US$439.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0884-2013: Evaluation of materials of health care product subject to radiation sterilization
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0884-2013	439	Add to Cart	4 days	Evaluation of materials of health care product subject to radiation sterilization	Valid

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Basic data

Standard ID: YY/T 0884-2013 (YY/T0884-2013)
Description (Translated English): Evaluation of materials of health care product subject to radiation sterilization
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.01
Word Count Estimation: 19,192
Quoted Standard: GB/T 1040.1; GB/T 1041-2008; GB/T 2411-2008; GB/T 3398.2-2008; GB/T 9341-2008; GB/T 13525; GB/T 16578.1-2008; GB/T 16886.1; HG/T 3862-2006; ISO 11137-1-2006; GB/T 2410-2008; GB/T 1040.2; GB/T 1040.3; GB/T 1040.4; GB/T 1040.5
Regulation (derived from): State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies: evaluation of health care products (including packaging) composed of materials, including polymers, metals, ceramics/glass and other materials for radiation sterilization process suitability procedures and information, for the sel

YY/T 0884-2013: Evaluation of materials of health care product subject to radiation sterilization

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Evaluation of materials of health care product subject to radiation sterilization ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Suitable for radiation sterilization of health care products Material Evaluation Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Select material 2 5 product design and processing 3 6 Material Testing 5 The basic principles of Appendix A (informative) adaptive radiation sterilization material 8 References 15

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard reference AAMITIR17.2008 Content "material and suitability for sterilization" (in English) about the radiating portion. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) and focal point responsible for the interpretation. This standard was drafted. Beijing Radiation Application Research Center, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shanghai Jinpeng source of radiation Technology Co., Ltd. The main drafters of this standard. Hu Yang, Hu Jinhui, Hua Hu phase, Hu Changming, Chen Qiang, SHEN Ling. Suitable for radiation sterilization of health care products Material Evaluation

1 Scope

This standard provides the evaluation of health care products (including packaging) of the constituent materials, including polymers, metals, ceramics/glass and other Material suitability radiation sterilization procedures and information processing, and for the selection and identification of health-care products and packaging materials to provide guidance.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Determination of GB/T 1040 (all parts) Tensile Properties of Plastics Measuring performance GB/T 1041-2008 plastic compression Determination of GB/T 2410-2008 transparent plastic light transmittance and haze GB/T 2411-2008 plastic and hard rubber Shore hardness GB/T 3398.2-2008 Plastics - Determination of hardness - Part 2. Rockwell hardness Determination of GB/T 9341-2008 plastic bending performance GB/T 13525 plastic tensile impact performance test methods GB/T Determination of plastic film and sheet tear resistance of 16578.1-2008 Part 1. Trouser tear method GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing HG/T 3862-2006 plastic yellow index test method ISO 11137-1.2006 Sterilization of health care products developed radiation - Part 1 medical device sterilization process, validation and often Regulatory control requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Absorbed dose Transfer to the dose of ionizing radiation on the substance of mass units. Note 1. The unit of absorbed dose is Gy (Gy), 1Gy = 1J/kg (= 100rad). Note 2. The standard dose refers absorbed dose. [ISO 11137-1.2006] 3.2 Health care products Medical devices, including in vitro diagnostic medical devices or pharmaceutical products, including biopharmaceuticals. Note. This standard is intended to illustrate the term health care products or product should refer to finished medical devices and/or additional components of the final package. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0884-2013_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0884-2013_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0884-2013_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0884-2013_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.